[Federal Register Volume 74, Number 66 (Wednesday, April 8, 2009)]
[Rules and Regulations]
[Pages 15880-15886]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-7820]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0272; FRL-8406-6]


Spiromesifen; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for the combined 
residues of spiromesifen (2-oxo-3-(2,4,6-trimethylphenyl)-1-
oxaspiro[4.4]non-3-en-4-yl 3,3-dimethylbutanoate) and its enol 
metabolite (4-hydroxy-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-
en-2-one), calculated as the parent compound equivalents, in or on pop 
corn grain and stover. Bayer CropScience requested these tolerances 
under the Federal Food, Drug, and Cosmetic Act (FFDCA). In addition, 
this regulation establishes tolerances for sweet corn, kernel, stover, 
and forage; and berry, lowgrowing, subgroup 13G. Interregional Research 
Project No. 4 (IR-4) requested these tolerances under the FFDCA. 
Additionally, the existing tolerance for strawberry is being deleted 
because it is superseded by the tolerances established for low growing 
berry subgroup 13-07G. Also, the tolerances for milk fat and meat 
byproducts of cattle, goats, horses, and sheep are being increased.In 
addition, this action establishes time-limited tolerances for the 
combined residues of spiromesifen (2-oxo-3-(2,4,6-trimethylphenyl)-1-
oxaspiro[4.4]non-3-en-4-yl 3,3-dimethylbutanoate) and its enol 
metabolite (4-hydroxy-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-
en-2-one), calculated as the parent compound equivalents, in or on 
soybean commodities in response to the approval of a specific exemption 
under section 18 of the Federal Insecticide, Fungicide, and Rodenticide 
Act (FIFRA) authorizing the use of spiromesifen on soybeans to control 
spider mites. The time-limited tolerances expire and are revoked on 
December 31, 2011.

DATES: This regulation is effective April 8, 2009. Objections and 
requests for hearings must be received on or before June 8, 2009, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

[[Page 15881]]


ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2008-0272. All documents in the 
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Jennifer Gaines, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-5967; e-mail address: [email protected]. Andrea 
Conrath, Registration Division (7505P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (703) 308-9356; e-mail 
address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to those 
engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to 
provide a guide for readers regarding entities likely to be affected by 
this action. Other types of entities not listed in this unit could also 
be affected. The North American Industrial Classification System 
(NAICS) codes have been provided to assist you and others in 
determining whether this action might apply to certain entities. If you 
have any questions regarding the applicability of this action to a 
particular entity, consult the person listed under FOR FURTHER 
INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing electronically available documents at 
http://www.regulations.gov, you may access this Federal Register 
document electronically through the EPA Internet under the ``Federal 
Register'' listings at http://www.epa.gov/fedrgstr. You may also access 
a frequently updated electronic version of EPA's tolerance regulations 
at 40 CFR part 180 through the Government Printing Office's e-CFR cite 
at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file 
an objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2008-0272 in the subject line on the first 
page of your submission. All requests must be in writing, and must be 
mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 
on or before June 8, 2009.
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit this copy, identified by docket ID number 
EPA-HQ-OPP-2008-0272, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Petition for Tolerance

    In the Federal Register of May 16, 2008 (73 FR 28462) (FRL-8361-6), 
EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 
346a(d)(3), announcing the filing of a pesticide petition (PP 8E7340) 
by Interregional Research Project Number 4 (IR-4), Rutgers, The State 
University of NJ, 500 College Road East, Suite 201 W. Princeton, NJ 
08540. The petition requested that 40 CFR 180.607 be amended by 
establishing tolerances for combined residues of the insecticide 
spiromesifen (2-oxo-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-
4-yl 3,3-dimethylbutanoate) and its enol metabolite (4-hydroxy-3-
(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-2-one), calculated as 
the parent compound equivalents, in or on corn, sweet, kernel plus cob 
with husks removed at 0.02 parts per million (ppm); corn, sweet, forage 
at 6.0 ppm, corn, sweet, stover at 7.0 ppm, berry and small fruit, low 
growing berry, subgroup 13-07G at 2.0 ppm and delete existing tolerance 
for strawberry at 2.0 ppm since residues of spiromesifen on strawberry 
will be covered by the tolerance proposed for berry and small fruit, 
low growing berry, subgroup. That notice referenced a summary of the 
petition prepared by IR-4 the registrant, which is available to the 
public in the docket, http://www.regulations.gov. There were no 
comments received in response to the notice of filing.
    In the Federal Register of November 5, 2008 (73 FR 65851) (FRL-
8385-1), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
8F7338) by Bayer CropScience, 2 T.W. Alexander Drive, P.O. Box 12014, 
Research Triangle Park, NC 27709. The petition requested that 40 CFR 
180.607 be amended by establishing tolerances for combined residues of 
the insecticide spiromesifen (2-oxo-3-(2,4,6-trimethylphenyl)-1-
oxaspiro[4.4]non-3-en-4-yl 3,3-dimethylbutanoate) and its enol 
metabolite (4-hydroxy-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-
en-2-one), calculated as the parent compound equivalents, in or on pop 
corn grain at 0.02 ppm and pop corn stover at 1.5 ppm. One comment was 
received on the notice of filing. EPA's response to this comment is 
discussed in Unit IV.C.

[[Page 15882]]

    Based upon review of the data supporting the petition, EPA has 
revised the tolerances on corn, sweet, forage; corn, sweet, stover; and 
berry and small fruit, low growing berry, subgroup 13-07G. The Agency 
has also determined from the residue data on the new uses that the 
tolerances for meat, byproducts of cattle, goats, horses, and sheep, 
and milk, fat need to be raised. The reason for these changes are 
explained in Unit IV.D.
    EPA is also establishing time-limited tolerances for residues of 
spiromesifen in or on soybean at 0.02 ppm; soybean, forage at 30 ppm; 
and soybean, hay at 86 ppm. These tolerances expire and are revoked on 
December 31, 2011. The Agency is establishing these time-limited 
tolerances in response to a specific exemption request under FIFRA 
section 18 on behalf of the Delaware Department of Agriculture for 
emergency use of spiromesifen on soybeans to control spider mites.
     According to the applicant, decreasing effectiveness of the 
available controls, coupled with season-long dry weather conducive to 
mite development, led to spider mite levels in soybean fields that were 
well above levels which would cause crop damage leading to significant 
economic losses. In the most heavily infested areas, significant yield 
losses of 50-70% were expected. Thus the applicant requested use of 
spiromesifen to address this emergency pest situation.
    As part of its assessment of the emergency exemption request, EPA 
assessed the potential risks presented by the residues of spiromesifen 
in or on these soybean commodities. In doing so, EPA considered the 
safety standard in section 408 (b) (2) of the FFDCA, and EPA decided 
that the necessary time-limited tolerances under section 408 (1) (6) of 
the FFDCA would be consistent with the safety standard and with FIFRA 
section 18. Consistent with the need to move quickly on the emergency 
exemption in order to address the urgent non-routine situation and to 
ensure that the resulting food is safe and lawful, EPA is issuing these 
time-limited tolerances without notice and opportunity for public 
comment as provided in section 408 (1) (6) of the FFDCA. Although, 
these time-limited tolerances expire and are revoked on December 31, 
2011, under section 408 (1) (5) of the FFDCA, residues of the pesticide 
not in excess of the amount specified in the tolerances remaining in or 
on soybeans, soybean hay, or soybean forage after that date will not be 
unlawful, provided the pesticide is applied in a manner that was lawful 
under FIFRA, and the residues do not exceed a level that was authorized 
by these time-limited tolerances at the time of application. EPA will 
take action to revoke these time-limited tolerances earlier if any 
experience with, scientific data, or other relevant information on this 
pesticide indicates that the residues are not safe.
    Because these time-limited tolerances are being approved under 
emergency conditions, EPA has not made any decisions about whether 
spiromesifen meets EPA's registration requirements for use on soybean 
or whether a permanent tolerance for this use would be appropriate. 
Under this circumstance, EPA does not believe that the time-limited 
tolerances serve as a basis for registration of spiromesifen by a State 
for special local needs under FIFRA section 24(c). Nor do the time-
limited tolerances serve as the basis for any State other than Delaware 
to use this pesticide on this crop under section 18 of FIFRA without 
following all provisions of EPA's regulations implementing FIFRA 
section 18 as identified in 40 CFR part 166. For additional information 
regarding the emergency exemption for spiromesifen, contact the 
Agency's Registration Division at the address provided under FOR 
FURTHER INFORMATION CONTACT.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors 
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure for the petitioned-for 
tolerances for combined residues of spiromesifen (2-oxo-3-(2,4,6-
trimethylphenyl)-1-oxaspiro[4.4]non-3-en-4-yl 3,3-dimethylbutanoate) 
and its enol metabolite (4-hydroxy-3-(2,4,6-trimethylphenyl)-1-
oxaspiro[4.4]non-3-en-2-one), calculated as the parent compound 
equivalents, on corn, sweet, forage at 6.0 ppm; corn, sweet, kernel 
plus cob with husks removed at 0.02 ppm; corn, sweet, stover at 7.0 
ppm; pop corn grain at 0.02 ppm; pop corn stover at 1.5 ppm; soybean at 
0.02 ppm; soybean, forage at 30 ppm; soybean, hay at 86 ppm; and berry 
and small fruit, low growing berry, subgroup 13-07G at 2.0 ppm. In 
addition, the available residue chemistry, toxicology or occupational 
databases supports the tolerances for milk, fat at 0.25 ppm; and meat, 
byproducts of cattle, goats, horses, and sheep at 0.20 ppm. EPA's 
assessment of exposures and risks associated with establishing 
tolerances follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children.
    Spiromesifen shows low acute toxicity via the oral, dermal and 
inhalation routes of exposure. It was neither an eye nor dermal 
irritant, but showed moderate potential as a contact sensitizer in a 
Magnusson and Kligman maximization assay. In short-term and long-term 
animal toxicity tests, the critical effects observed were loss of body 
weight, adrenal effects (discoloration, decrease in fine vesiculation, 
and the presence of cytoplasmic eosinophilia in zona fasciculata 
cells), thyroid effects (increased thyroid stimulating hormone, 
increased thyroxine binding capacity, decreased T3 and 
T4 levels, colloidal alteration and thyroid follicular cell 
hypertrophy), liver effects (increased alkaline phosphatase, ALT and 
decreased cholesterol, triglycerides), and spleen effects (atrophy, 
decreased spleen cell count, and increased macrophages). Spiromesifen 
shows no significant developmental or reproductive effects, is not 
likely to be carcinogenic based on bioassays in rat and mouse, and 
lacks in vivo and in vitro mutagenic effects. Spiromesifen is not 
considered a neurotoxic chemical based on the chemical's mode of action

[[Page 15883]]

and the available data from multiple studies, including acute and 
subchronic neurotoxicity studies.
    Specific information on the studies received and the nature of the 
adverse effects caused by spiromesifen as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document Spiromesifen: Human-Health Risk 
Assessment for Proposed Section 3 Uses on Pop Corn, Sweet Corn, Low-
Growing Berry Subgroup; and Section 18 Emergency Exemption Use on 
Soybean, pages 17-25 in docket ID number EPA-HQ-OPP-2008-0272 and memo, 
D300469, February 17, 2005.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, a toxicological point of departure (POD) is 
identified as the basis for derivation of reference values for risk 
assessment. The POD may be defined as the highest dose at which no 
adverse effects are observed (the NOAEL) in the toxicology study 
identified as appropriate for use in risk assessment. However, if a 
NOAEL cannot be determined, the lowest dose at which adverse effects of 
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach 
is sometimes used for risk assessment. Uncertainty/safety factors (UFs) 
are used in conjunction with the POD to take into account uncertainties 
inherent in the extrapolation from laboratory animal data to humans and 
in the variations in sensitivity among members of the human population 
as well as other unknowns. Safety is assessed for acute and chronic 
dietary risks by comparing aggregate food and water exposure to the 
pesticide to the acute population adjusted dose (aPAD) and chronic 
population adjusted dose (cPAD). The aPAD and cPAD are calculated by 
dividing the POD by all applicable UFs. Aggregate short-term, 
intermediate-term, and chronic-term risks are evaluated by comparing 
food, water, and residential exposure to the POD to ensure that the 
margin of exposure (MOE) called for by the product of all applicable 
UFs is not exceeded. This latter value is referred to as the Level of 
Concern (LOC).
    For non-threshold risks, the Agency assumes that any amount of 
exposure will lead to some degree of risk. Thus, the Agency estimates 
risk in terms of the probability of an occurrence of the adverse effect 
greater than that expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for spiromesifen used for 
human risk assessment can be found at http://www.regulations.gov in 
document Spiromesifen: Human-Health Risk Assessment for Proposed 
Section 3 Uses on Pop Corn, Sweet Corn, Low-Growing Berry Subgroup; and 
Section 18 Emergency Exemption Use on Soybean, page 25 in docket ID 
number EPA-HQ-OPP-2008-0272.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to spiromesifen, EPA considered exposure under the petitioned-
for tolerances as well as all existing spiromesifen tolerances in (40 
CFR 180.607). EPA assessed dietary exposures from spiromesifen in food 
as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure.
    No such effects were identified in the toxicological studies for 
spiromesifen; therefore, a quantitative acute dietary exposure 
assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 1994-1996 
and 1998 CSFII. As to residue levels in food, EPA assumed tolerance-
level residues for all commodities except for the leafy-green and 
leafy-Brassica vegetable subgroups (4A and 5B). The tolerance values 
for leafy vegetables were adjusted upward to account for the metabolite 
BSN 2060-4-hydroxymethyl (free and conjugated), which is a residue of 
concern in leafy vegetables for risk assessment purposes only. EPA used 
data from the metabolism studies to create a tolerance-equivalent value 
for the parent spiromesifen and the BSN 2060-4-hydroxymethyl metabolite 
to estimate residues in leafy vegetables. DEEM 7.81 default processing 
factors and 100 percent crop treated (PCT) were assumed for all 
commodities.
    iii. Cancer. Due to no evidence of carcinogenic effects in the 
submitted rat and mouse cancer studies, spiromesifen has been 
classified as ``not likely to be carcinogenic to humans.'' Therefore, 
an exposure assessment to evaluate cancer risk was not performed.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue and/or PCT information in the dietary assessment 
for spiromesifen. Tolerance level residues were used for all food 
commodities except for the leafy-green and leafy-Brassica vegetable 
subgroups (4A and 5B). For these subgroups, the residue values were 
adjusted to account for the metabolite BSN 2060-4-hydroxymethyl (free 
and conjugated), which is a residue of concern in leafy vegetables for 
risk assessment purposes only. 100 PCT was assumed for all food 
commodities.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring data to complete a comprehensive dietary exposure 
analysis and risk assessment for spiromesifen in drinking water. 
Because the Agency does not have comprehensive monitoring data, the 
Agency used screening level water exposure models in the dietary 
exposure analysis and risk assessment for spiromesifen in drinking 
water. These simulation models take into account data on the physical, 
chemical, and fate/transport characteristics of spiromesifen. Further 
information regarding EPA drinking water models used in pesticide 
exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Parent spiromesifen is not likely to persist in the environment as 
it readily undergoes both biotic and abiotic degradation; however, its 
primary degradate BSN2060-enol is expected to persist. While parent 
spiromesifen strongly sorbs to sediment and is not likely to be mobile, 
its major degradates, BSN2060-enol and BSN2060-carboxy, do not sorb to 
sediment and are expected to leach into ground water. Spiromesifen has 
limited solubility in water (130 [micro]g/L at 25[deg]C) and in some 
cases has been reported to have a practical solubility of 40 to 50 
[micro]g/L. The pesticide degrades primarily through aerobic soil 
metabolism and hydrolysis; however, in clear shallow water it will 
ready undergo photolysis. Field studies indicate that spiromesifen 
readily dissipates with field dissipation half-lives ranging from 2 to 
10 days.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of 
spiromesifen for chronic exposure are 188 parts per billion (ppb) for 
surface water and 86 ppb for ground water. For chronic dietary risk 
assessment, the water concentration of value 188 ppb was used to assess 
the contribution to drinking water. Modeled estimates of drinking water 
concentrations were

[[Page 15884]]

directly entered into the dietary exposure model.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    Spiromesifen is not registered for any specific use patterns that 
would result in residential exposure.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA has not found spiromesifen to share a common mechanism of 
toxicity with any other substances, and spiromesifen does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
spiromesifen does not have a common mechanism of toxicity with other 
substances. For information regarding EPA's efforts to determine which 
chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see EPA's website at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(c) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA safety 
factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. There is no evidence of 
increased susceptibility of rats or rabbits to in utero and/or 
postnatal exposure to spiromesifen. In the prenatal developmental 
toxicity studies in rats and rabbits and in the 2-generation 
reproduction study in rats, developmental toxicity to the offspring 
occurred at equivalent or higher doses than parental toxicity.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X. That decision is based on the following 
findings:
    i. The toxicity database for spiromesifen is complete and no 
additional immunotoxicity of neurotoxicty testing is required. The 
rationale is described in this Unit:
    a. Because spleen effects were seen in several toxicity studies, 
the registrant pursued specialized immunotoxicity studies in rats and 
mice that were both negative. These studies satisfy the revised part 
158 requirement for immunotoxicity testing. In addition, the endpoints 
selected for the risk assessment are considered protective of any 
possible immunotoxic effects.
    b. There is no concern for neurotoxicity resulting from exposure to 
spiromesifen. Neurotoxic effects such as reduced motility, spastic 
gait, increased reactivity, tremors, clonic-tonic convulsions, reduced 
activity, labored breathing, vocalization, avoidance reaction, 
piloerection, limp, cyanosis, squatted posture, and salivation were 
observed in two studies (5-day inhalation and subchronic oral rat) at 
high doses (134 and 536 milligrams/kilogram/day (mg/kg/day), 
respectively). These effects were neither reflected in 
neurohistopathology nor in other studies. Because these effects were 
not observed in the acute and subchronic neurotoxicity studies, they 
were not considered reproducible. Thus, based on the chemical's mode of 
action and the available data from multiple studies, the chemical is 
not considered neurotoxic.
    ii. There is no evidence that spiromesifen results in increased 
susceptibility in utero rats or rabbits in the prenatal developmental 
studies or in young rats in the 2-generation reproduction study. A 
developmental neurotoxicity study is not required.
    iii. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 PCT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground water and surface water modeling 
used to assess exposure to spiromesifen in drinking water. These 
assessments will not underestimate the exposure and risks posed by 
spiromesifen.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are 
safe by comparing aggregate exposure estimates to the aPAD and cPAD. 
The aPAD and cPAD represent the highest safe exposures, taking into 
account all appropriate SFs. EPA calculates the aPAD and cPAD by 
dividing the POD by all applicable UFs. For linear cancer risks, EPA 
calculates the probability of additional cancer cases given the 
estimated aggregate exposure. Short-term, intermediate-term, and 
chronic-term risks are evaluated by comparing the estimated aggregate 
food, water, and residential exposure to the POD to ensure that the MOE 
called for by the product of all applicable UFs is not exceeded.
    1. Acute risk. An acute aggregate risk assessment takes into 
account exposure estimates from acute dietary consumption of food and 
drinking water. No adverse effect resulting from a single-oral exposure 
was identified and no acute dietary endpoint was selected. Therefore, 
an acute aggregate exposure assessment was not conducted.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
spiromesifen from food and water will utilize 77% of the cPAD for (all 
infants <1 year old) the population group receiving the greatest 
exposure.
    3. Short-term risk and intermediate-term risk. Short-term and 
intermediate-term aggregate exposure takes into account short-term 
residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level).
    Spiromesifen is not registered for any use patterns that would 
result in residential exposure. Therefore, the short-term aggregate 
risk is the sum of the risk from exposure to spiromesifen through food 
and water and will not be greater than the chronic aggregate risk.
    4. Aggregate cancer risk for U.S. population. Spiromesifen has been 
classified as ``not likely to be carcinogenic to humans.'' Spiromesifen 
is not expected to pose a cancer risk.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to spiromesifen residues.

[[Page 15885]]

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology high-performance liquid 
chromatography/mass spectroscopy (HPLC/MS/MS)/Method 00631/M001) is 
available to enforce the tolerance expression. The method may be 
requested from: Chief, Analytical Chemistry Branch, Environmental 
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone 
number: (410) 305-2905; e-mail address: [email protected].

B. International Residue Limits

    No Codex, Canadian, or Mexican MRLs have been established for 
residues of spiromesifen and its metabolites on the requested crops.

C. Response to Comments

    One comment was received from a private citizen who opposed the 
authorization to sell to any pesticide that leaves a residue on food. 
The Agency has received this same comment from this commenter on 
numerous previous occasions and rejects it for the reasons previously 
stated in the Federal Register of January 7, 2005 (70 FR 1349) (FRL-
7691-4.)

D. Revisions to Petitioned-For Tolerances

    1. Corn, sweet, forage; corn, sweet, stover; corn, pop, grain; 
corn, pop, stover; and berry, lowgrowing, subgroup 13G: Using the North 
American Free Trade Agreement (NAFTA) Maximum Residue Limit (MRL) 
Tolerance Harmonization Workgroup methodology for evaluating field 
trial data, the Agency determined that the following modifications to 
the requested tolerances should be made: Corn, sweet, forage proposed 
at 6.0 ppm should be 17 ppm; and corn, sweet, stover proposed at 7.0 
ppm should be 12 ppm. Additionally, the terminology should be corrected 
for berry and small fruit, low growing berry, subgroup 13-07G.2.
    2. Meat, byproducts of cattle, goats, horses, and sheep; milk, fat: 
The Agency has also determined from the residue data on the new uses, 
the newly calculated maximum reasonable dietary burden for dairy 
cattle, and the reside data from an available ruminant feeding study, 
it is appropriate to raise the tolerances for meat, byproducts of 
cattle, goats, horses, and sheep to 0.20 ppm; and to raise the 
tolerance for milk, fat to 0.25 ppm.

V. Conclusion

    Therefore, tolerances are established for combined residues of 
insecticide spiromesifen (2-oxo-3-(2,4,6-trimethylphenyl)-1-
oxaspiro[4.4]non-3-en-4-yl 3,3-dimethylbutanoate) and its enol 
metabolite (4-hydroxy-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-
en-2-one), calculated as the parent compound equivalents, in or on 
corn, sweet, kernel plus cob with husks removed at 0.02 ppm; corn, 
sweet, forage at 17 ppm; corn, sweet, stover at 12 ppm; berry and small 
fruit; berry, lowgrowing, subgroup 13G at 2.0 ppm and delete existing 
tolerance for strawberry at 2.0 ppm since residues of spiromesifen on 
strawberry will be covered by the tolerance proposed for berry and 
small fruit, low growing berry, subgroup. In addition, this regulation 
establishes time-limited tolerances for residues of spiromesifen and 
its enol metabolite, in or on soybeans at 0.02 ppm; soybean, forage at 
30 ppm; and soybean, hay at 86 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this final rule has been 
exempted from review under Executive Order 12866, this final rule is 
not subject to Executive Order 13211, entitled Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
Protection of Children from Environmental Health Risks and Safety Risks 
(62 FR 19885, April 23, 1997). This final rule does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any 
special considerations under Executive Order 12898, entitled Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, such as the tolerance in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (Public Law 104-4).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. EPA will submit a report 
containing this rule and other required information to the U.S. Senate, 
the U.S. House of Representatives, and the Comptroller General of the 
United States prior to publication of this final rule in the Federal 
Register. This final rule is not a ``major rule'' as defined by 5 
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: March 30, 2009.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:


[[Page 15886]]


    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Section 180.607 is amended as follows:
0
i. In paragraph (a)(1), in the table, by removing the commodity 
strawberry and alphabetically adding the following commodities;
0
ii. In paragraph (a)(2), in the table, by revising the tolerance level 
for cattle, meat byproducts; goat, meat by products; horse, meat 
byproducts; milk, fat; and sheep, meat byproducts; and
0
iii. By adding paragraph (b).
    The amendments read as follows:


Sec.  180.607  Spiromesifen; tolerances for residues.

    (a) General. (1) * * *

------------------------------------------------------------------------
              Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Berry and small fruit, low growing                                   2.0
 berry, subgroup 13-07G.............
                                * * * * *
Corn, pop, grain....................                                0.02
Corn, pop, stover...................                                 4.0
Corn, sweet, forage.................                                  17
Corn, sweet, kernel plus cob with                                   0.02
 husks removed......................
                                * * * * *
Corn sweet, stover..................                                  12
                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
              Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Cattle, meat byproducts.............                                0.20
                                * * * * *
Goat, meat byproducts...............                                0.20
                                * * * * *
Horse, meat byproducts..............                                0.20
                                * * * * *
Milk, fat...........................                                0.25
                                * * * * *
Sheep, meat byproducts                                              0.20
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. Time-limited tolerances 
specified in the following table are established for combined residues 
of spiromesifen, (2-oxo-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-
en-4-yl 3,3-dimethylbutanoate) and its enol metabolite (4-hydroxy-3-
(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-2-one), calculated as 
the parent compound equivalents in or on the specified agricultural 
commodities, resulting from use of the pesticide pursuant to FFIFRA 
section 18 emergency exemptions. The tolerances expire and are revoked 
on the date specified in the table.

----------------------------------------------------------------------------------------------------------------
                Commodity                          Parts per million              Expiration/revocation date
----------------------------------------------------------------------------------------------------------------
Soybean, seed...........................                                0.02                            12/31/11
Soybean, forage.........................                                  30                            12/31/11
Soybean, hay............................                                  86                            12/31/11
----------------------------------------------------------------------------------------------------------------

[FR Doc. E9-7820 Filed 4-7-09; 8:45 am]
BILLING CODE 6560-50-S